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Dianthus Therapeutics (NASDAQ:DNTH) revealed on Wednesday that the U.S. FDA has greenlit its investigational new drug (IND) application, paving the way for the commencement of a Phase 2 trial for DNTH103, its premier asset aimed at addressing multifocal motor neuropathy (MMN), a rare neuromuscular disorder.
The Phase 2 trial, named MoMeNtum, is tailored to accommodate 36 MMN patients. The trial protocol stipulates an initial treatment duration of 17 weeks, followed by a 52-week open-label extension. This multi-national trial is projected to yield pivotal data in the latter half of 2026.
Unlike prevailing medical practices that rely on intravenous or subcutaneous infusions for MMN therapies, DNTH103, which centers on the inhibition of the C1s protein in the complement pathway, is administered via subcutaneous self-injections.
One can only marvel at the potential transformation DNTH103 might induce in the lives of MMN patients, as articulated by Hans Katzberg, an esteemed Associate Professor of Neurology at the University of Toronto.
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